Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis (NCT NCT00464438)
NCT ID: NCT00464438
Last Updated: 2011-09-21
Results Overview
Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
COMPLETED
PHASE4
171 participants
Day 7
2011-09-21
Participant Flow
Participant milestones
| Measure |
Gatifloxacin 0.3%
|
Moxifloxacin 0.5%
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
|
Overall Study
COMPLETED
|
83
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Baseline characteristics by cohort
| Measure |
Gatifloxacin 0.3%
n=85 Participants
|
Moxifloxacin 0.5%
n=86 Participants
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
15.2 days
STANDARD_DEVIATION 6.59 • n=99 Participants
|
15.2 days
STANDARD_DEVIATION 6.05 • n=107 Participants
|
15.2 days
STANDARD_DEVIATION 6.31 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria.
Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Outcome measures
| Measure |
Gatifloxacin 0.3%
n=56 Participants
|
Moxifloxacin 0.5%
n=64 Participants
|
|---|---|---|
|
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
|
78.6 Percentage of Patients
|
84.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Day 7Population: Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria
Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).
Outcome measures
| Measure |
Gatifloxacin 0.3%
n=56 Participants
|
Moxifloxacin 0.5%
n=64 Participants
|
|---|---|---|
|
Percentage of Patients With Microbiological Improvement
|
94.6 Percentage of Patients
|
92.2 Percentage of Patients
|
SECONDARY outcome
Timeframe: Days 7Population: Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria
Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Outcome measures
| Measure |
Gatifloxacin 0.3%
n=56 Participants
|
Moxifloxacin 0.5%
n=64 Participants
|
|---|---|---|
|
Percentage of Patients With Improvement in Ocular Signs for Lid Erythema
|
76.8 Percentage of Patients
|
75.0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Day 7Population: Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria
Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Outcome measures
| Measure |
Gatifloxacin 0.3%
n=56 Participants
|
Moxifloxacin 0.5%
n=64 Participants
|
|---|---|---|
|
Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7
|
94.6 Percentage of Patients
|
92.2 Percentage of Patients
|
Adverse Events
Gatifloxacin 0.3%
Moxifloxacin 0.5%
Serious adverse events
| Measure |
Gatifloxacin 0.3%
n=84 participants at risk
|
Moxifloxacin 0.5%
n=86 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Pyrexia
|
0.00%
0/84
Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
|
1.2%
1/86
Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
|
Other adverse events
| Measure |
Gatifloxacin 0.3%
n=84 participants at risk
|
Moxifloxacin 0.5%
n=86 participants at risk
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
4.8%
4/84
Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
|
3.5%
3/86
Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
|
|
Infections and infestations
Conjunctivitis bacterial
|
8.3%
7/84
Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
|
5.8%
5/86
Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER